Kornimate/medical-research-clean huggingface dataset:
oxytocin on approach bias and craving

Conditions: Alcohol Use Disorder

Summary: this will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. this study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. in this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.


Eligibility criteria:
inclusion criteria: * healthy volunteers who are 21-40 years of age * if female, 10 or more alcoholic drinks must be consumed weekly. * if male, 14 or more alcoholic drinks must be consumed weekly. * meets dsm-v criteria for alcohol use disorder (aud). * score 8 or greater on the alcohol use disorders identification test (audit) * if female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[iud\], hormonal birth control, or barrier method). * native english speaker * right handed * high school graduate or equivalent. * able and willing to provide an informed consent. * able to understand and follow the instructions of the investigator exclusion criteria: * positive urine drug screen (except marijuana). * using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana). * marijuana use more than 3 times/week. * current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use. * currently trying to quit alcohol use. * history of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.). * has a history of atrophic rhinitis, recurrent nose bleeds, cranial surgical procedures, hypophysectomy, chronic congestion, or sinus problems. * has a history of cardiac arrhythmia. * clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician. * severely low blood (\ 160/100). * sgpt/alt or sgot/ast values greater than 2x upper limit of normal. * bac level \> 0.00% at the beginning of screening visit (within margin of error of detection). * has a neurological dysfunction or psychiatric disorder (confirm with study physician). * has a history of brain trauma (confirm with study physician). * has an allergy or intolerance to oxytocin. * has received an investigational drug within 30 days of screening visit. * has any mri scanning contraindications. * has a history of claustrophobia.
the efficacy of the longeviti clearfit implant in craniectomies for post-operative monitoring in chronic subdural hematomas

Conditions: Chronic Subdural Hematoma

Summary: chronic subdural hematomas are frequent neurosurgical issues that are most often treated with burr hole craniectomies to drain the subdural fluid. at the chronic stage, a subdural hematoma is more liquified and easily washed out through burr hole openings. however, it often requires frequent imaging and monitoring to ensure that fluid does not reaccumulate in the subdural space, that the washout was adequate, and that further intervention/repeat intervention is not required, particularly if the patient develops acute changes in neurologic status or lacks improvement in initial symptomatology. therefore, these patients require multiple repeated ct head images during their inpatient and post-operative follow-up course. this leads to high radiation doses to patients and high-cost burden. the longeviti clearfit cover was developed to allow for ultrasound imaging through the implanted cover. the skull's acoustic properties prevent ultrasound from being used through the bone, therefore limiting its use in post-operative neurosurgical patients. using ultrasound would remove the need for high radiation doses with ct, could be done very quickly and easily at bedside or in the clinic to check subdural space or ventricle size, and is much lower cost. this clearfit implant would be utilized in place of a burr hole cover, typically titanium, that is implanted in most other cases. the aim of this study is to prospectively assess patients with surgically treated chronic subdural hematomas via craniectomy that have the craniectomy site covered with the longeviti clearfit, compared retrospectively to a matched cohort of patients that had their craniectomy site for the same procedure covered with the typically used titanium/metal. this will allow us to determine if this new implant results in reduced need for repeated ct imaging by utilizing bedside clinician-performed ultrasound and reduces overall cost for patients.


Eligibility criteria:
inclusion criteria: * adult patients \>18 years old; patients determined by surgeon to have a chronic subdural hematoma that is treated with craniectomy that would allow for implantation of a clearfit cover exclusion criteria: * pediatric patients, patient with allergy to the material the implant is made with (polymethylmethacrylate)
allograft meniscal arthroplasty for the treatment of basal joint arthritis of the thumb

Conditions: Arthritis

Summary: hypothesis: the use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb. a variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. problems with persistent pain and poor function have been reported to some degree for each of these procedures. using the concept of an implant acting as a spacer and stabilizer the investigators proposed and implemented a novel surgical technique using allograft knee meniscus as a biologic implant for the treatment of basal joint arthritis of the thumb.

hypothesis: the use of knee meniscal allograft as a joint spacer and stabilizer is a viable option for the surgical treatment of basal joint arthritis of the thumb. introduction: a variety of surgical procedures have been developed for the treatment of basal joint osteoarthritis of the thumb. problems with persistent pain and poor function have been reported to some degree for each of these procedures. promising results were originally reported (2004) for the artelon carpometacarpal (cmc) implant (small bone innovations, morrisville, pa) procedure which utilized the concept of a spacer and stabilizer of the cmc joint . recent studies however, have demonstrated problems due to a foreign body reaction with the artelon implant requiring revision surgery. using the concept of an implant acting as a spacer and stabilizer we proposed and implemented the use of allograft knee meniscus as a biologic implant in the treatment of basal joint arthritis of the thumb methods: a prospective study was performed on four thumbs using an allograft knee meniscus transplanted into the thumb cmc joint using the surgical technique described for that of the artelon implant (small bone innovations, morrisville, pa). data collected included: pain level, grip strength, tip, key and pinch strength, carpometacarpal, metacarpophalangeal, interphalangeal, and oppositional range of motion, as well as disabilities of the arm, shoulder, and hand (dash) scores. interval radiographic analysis is to be performed. endpoints for data collection will be at three months, six months, one, two, three, four, and five years follow up.

Eligibility criteria:
inclusion criteria: * stage i - iii osteoarthritis / traumatic arthritis of the thumb. exclusion criteria: * exclusion criteria were diabetes mellitus, kidney insufficiency, oa in the stt joint, or malignancy within the past 10 years.

Keywords: allograft arthroplasty basal joint carpometacarpal joint thumb meniscus osteoarthritis patients with stages i - iii arthritis of the the thumb carpometacarpal joint
safety and effectiveness of flaxseed for reducing high cholesterol

Conditions: Hypercholesterolemia

Summary: flaxseed, a rich source of fiber, may be a significant component of a cholesterol-reducing diet. the purpose of this study is to evaluate the safety and effectiveness of flaxseed in reducing high cholesterol.

hypercholesterolemia is an established risk factor for atherosclerotic cardiovascular disease (ascvd). the national cholesterol education program estimates that 65 million americans with hypercholesterolemia could be treated with diet and exercise alone. flaxseed is a potential component of cholesterol-reducing diet regimens. flaxseed contains significant amounts of soluble fiber and is a rich source of both alpha-linolenic acid and phytoestrogenic ligands, which have been implicated in the prevention of ascvd. however, flaxseed's phytoestrogenic ligands may have undesirable hormonal effects. this study will systematically evaluate the safety and efficacy of ground flaxseed ingestion in both men and women with hypercholesterolemia. participants will be randomized to receive flaxseed or a matching wheat bran control. the test dose of flaxseed will be 40 grams administered in baked products (muffins, bread, or bars). the first 6 study weeks are a diet stabilization phase, followed by a 10-week study phase in which participants are expected to eat two servings of the test food daily. blood and urine are collected for analysis, which will include measurement of low density lipoprotein cholesterol (ldl-c), post-prandial triglycerides, and urinary isoprostane secretion.

Eligibility criteria:
inclusion criteria * men over 45 and post-menopausal women * ldl cholesterol \> 130 mg/dl exclusion criteria * established heart, kidney, or liver disease * diabetes * cancer

Keywords: flaxseed cholesterol
bi-level vs. single level esb in vats

Conditions: Acute Pain

Summary: video assisted thoracoscopic surgery (vats) is a minimally invasive surgery to remove lesions from the thoracic cavity. it is associated with moderate pain which can lead to pulmonary complications after surgery. the enhanced recovery after surgery (eras) and the european society of thoracic surgeons recommended a multimodal analgesia approach to manage pain after vats. erector spinae block (esb) is a popular analgesic block due to its ease of performance and wide coverage. it has been shown to be effective in randomized control trials. recently, case reports on bi-level esb are emerging, suggesting more effective analgesia compared to single level esb. as there is no available data, the investigators are interested in conducting a randomized pilot study, comparing bi-level to single level esb to gather baseline data for sample size calculation for a formal randomized trial.


Eligibility criteria:
inclusion criteria: * adult patients (at least 18 years old) * elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via vats exclusion criteria: * history of malignant hyperthermia * bmi \> 40, chronic pain condition * daily opioid consumption of more than 60 mg oral morphine equivalents * conversion to thoracotomy * insertion of epidural * postoperative admission to icu
the mollie study, a study to evaluate the safety and efficacy of the mollie medical device

Conditions: Dyspareunia

Summary: study to evaluate the use of a medical device in relieving collision dyspareunia


Eligibility criteria:
inclusion criteria: females 18 years of age and older with a diagnosis of collision dyspareunia - exclusion criteria: -
a phase ii study with tumor molecular pharmacodynamic (mpd) evaluation of oral mtor-inhibitor everolimus (rad001) 10 mg daily in patients suffering from classic or endemic kaposi's sarcoma

Conditions: Kaposi Sarcoma

Summary: classic kaposi's sarcoma (cks) is an angioproliferation associated with human herpes virus 8 (hhv8), which sometimes requires systemic treatment. rapamycin and everolimus are mtor inhibitors. the pi3k-akt-mtor pathway is activated in cks.the aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in cks. patients suffering from cks will be enrolled in a multicenter two-stage phase ii trial. at inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral cks. the primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per actg criteria). the trial is planned using simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type i error rate 2.5% and power of 90%. accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage.

the primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per actg criteria). secondary endpoints are response according to physician global assessment, lesions size , lesions infiltration, lymphedema, tolerance, pharmacodynamic (pathologic, angiogenic and lymphangiogenic biomarkers, hhv8 viral load sequential evaluation in the lesions, pharmacokinetic evaluation.

Eligibility criteria:
inclusion criteria: histologic confirmed classic or endemic ks (non transplant non hiv patients) \> 18 years old at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral ks presence of at least 4 targets lesions \> 5mm at least 4 weeks wash out from any ks specific therapy ecog \< 2 exclusion criteria: immunosupressive regimen patients hiv positive creatinine clearance \ 3n, neutropénia\<1500, thrombopenia\<150000, anemia\<8g/dl

Keywords: mtor inhibitors
inhaled nitric oxide for the adjunctive therapy of severe malaria: a randomized controlled trial

Conditions: Severe Malaria

Summary: despite the use of highly effective anti-malarial medications, 10-30% of african children with severe malaria will die, underscoring the need for adjunctive therapies that can be applied in endemic areas. a clinical trial of adjunctive inhaled nitric oxide (ino) in severe malaria is warranted on the basis of firm proof of concept from animal studies and a human study using the no donor l-arginine, together with evidence of safety from clinical experience and trials of ino for other conditions. our objective is to determine whether supplemental ino (80 ppm) in addition to ugandan standard of care treatment reduces levels of angiopoietin-2 (ang-2), a quantitative biomarker of malaria severity, in children with severe malaria compared to standard of care treatment alone. we will conduct a randomized placebo-controlled trial among children 1-10 years of age admitted to jinja hospital (uganda) with severe malaria to test the efficacy of inhaled nitric oxide in severe malaria.

severe malaria remains a major cause of global morbidity and mortality. while the use of artemisinin-based antimalarial therapy has improved outcomes in severe malaria, the mortality rate remains high. adjunctive therapies that target the underlying pathophysiology of severe malaria may further reduce morbidity and mortality. endothelial activation plays a central role in the pathogenesis of severe malaria, of which the angiogenic factors angiopoietin-1 (ang-1) and angiopoietin-2 (ang-2) have recently been shown to function as key regulators. nitric oxide (no) is a major inhibitor of ang-2 release from endothelium and has been shown to decrease endothelial inflammation and reduce the adhesion of parasitized erythrocytes. low-flow inhaled nitric oxide gas (ino) is a us fda-approved treatment for hypoxic respiratory failure in neonates. based on compelling data on the efficacy of ino in experimental cerebral malaria in animal models, coupled with the documented safety of ino in clinical practice and trials for other diseases, we propose a randomized clinical trial of ino for the adjunctive treatment of severe malaria in ugandan children.

Eligibility criteria:
inclusion criteria: * age 1-10 years * positive malaria rapid diagnostic test in the presence of any of the features of severe malaria * willing and able to complete follow up schedules for the study - 14 day and 6 months after hospital discharge exclusion criteria: * baseline methemoglobinemia * known renal, cardiac, or hepatic disease or other chronic illnesses like diabetes, epilepsy, cerebral palsy, clinical aids * severe malnutrition * severe malarial anemia without other signs of severe malaria

Keywords: malaria children
clinical study to evaluate the treatment of gingivitis of two toothpastes

Conditions: Dental Plaque

Summary: the objective is to compare two commerical oral products for the treatment of gingivitis.


Eligibility criteria:
inclusion criteria: 1. male or female volunteers 18-65 years of age 2. good general health 3. must sign informed consent form 4. minimum of 16 natural uncrowned teeth (excluding third molars) must be present. 5. no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. 6. dental selection criteria: gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a gi score of ≥ 3. subjects will be stratified according to gingivitis severity. average full mouth gi score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. target a full mouth pi (quigley-hein) to be in the range of 1.5-3.0 exclusion criteria: 1. subjects unable or unwilling to sign the informed consent form. 2. medical condition which requires pre-medication prior to dental visits/procedures 3. moderate or advanced periodontal disease 4. history of allergy to iodine 5. history of thyroid disease 6. history of diabetes 7. 2 or more decayed untreated dental sites at screening. 8. other disease of the hard or soft oral tissues. 9. impaired salivary function (e.g. sjogren's syndrome or head and neck irradiation). 10. use of medications that are currently affect salivary flow. 11. use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. 12. pregnant or nursing women. 13. participation in any other clinical study within 1 week prior to enrollment into this study. 14. use of tobacco products 15. subjects who must receive dental treatment during the study dates. 16. current use of antibiotics for any purpose. 17. presence of an orthodontic appliance. 18. history of allergy to common dentifrice ingredients 19. immune compromised individuals (hiv, aids, immuno suppressive drug therapy) 20. women of childbearing potential and not on birth control (diaphragm, birth control pills or implants, iud (intrauterine device), condoms). 21. smoker
penetration of cefazolin into hepatic cysts

Conditions: Hepatic Cyst

Summary: hepatic cysts are fluid-filled cavities located in the liver parenchyma. they are usually asymptomatic, but can cause mass-related symptoms as abdominal pain, dyspnea and nausea. aspiration sclerotherapy is indicated in patients with a dominant hepatic cyst to alleviate symptoms by draining the hepatic cyst to reduce cyst diameter. spontaneous cyst infection, or following aspiration sclerotherapy, presents a severe complication of hepatic cystic disease requiring frequent hospitalization, long-term antibiotic treatment, and in some invasive therapies. evidence that antibiotics are able to reach adequate intracystic concentration is however lacking. to prevent procedure-related cyst infection in patients receiving aspiration sclerotherapy, cefazolin prophylaxis is given as standard of care. in this study we want to assess the hepatic cyst penetration capacity of cefazolin by comparing serum and cyst fluid concentrations of cefazolin. we hypothesize that cefazolin is able to penetrate hepatic cysts, with treatment naïve cyst allowing a better penetration, reducing the risk of developing cyst infection following aspiration sclerotherapy.


Eligibility criteria:
inclusion criteria: * age ≥18 years * indication for aspiration and sclerotherapy * providing informed consent exclusion criteria: * presence of an arteriovenous fistula, history of mastectomy or lymph node dissection at both extremities * signs of phlebitis, defined as localized skin redness and swelling, at both extremities * history of cephalosporin and/or penicillin allergy consisting of ige-mediated reactions as anaphylaxis, angioedema, urticaria. * any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator.

Keywords: penetration cefazolin hepatic cyst
intensive insulin therapy as therapeutic strategy for non-diabetic hyperglycemia after surgery in icu

Conditions: Hyperglycemia; Postoperative Complications; Insulin Resistance

Summary: the current study hypothesizes that the use of intravenous intensive insulin therapy (iv-iit) may be beneficial than iv conventional insulin therapy (iv-cit) for improving the outcome of non-diabetic surgical patients had postoperative (po) stress hyperglycemia (psh).

all postoperative patients who will be admitted to surgical icu and develop (psh) will be eligible for evaluation for inclusion and exclusion criteria. prior to initiation of iv-it (insulin therapy), blood samples will be obtained to estimate base-line blood glucose level (bg). bg will be estimated hourly during iv-it to guard against development of hypoglycemic episodes. the assigned iv-it will continue till reaching the target bg for each group and then will be stopped and patients will be shifted to subcutaneous (sc)-it. during maintenance sc-it, bg level will be estimated 6-hourly to assure maintenance of bg within the desired range, otherwise if hyperglycemia recurred or its induced complications as hyperglycemic ketoacidosis or hyperosmolar coma or infectious complications developed, iv-it will be resumed and bg will be followed-up hourly. the same sequence of follow-up will be continued till stability of bg at the targeted level. iv-it will be provided as following : conventional insulin therapy (cit) will be provided as a continuous infusion of 50 iu of actrapid hm in 50 ml of 0.9% sodium chloride using a pump. infusion will be adjusted to achieve bg level in range of 180-200 mg/dl. intensive insulin therapy (iit) will be provided as an insulin infusion at rate of 1 mu/kg/min and will be adjusted to achieve target bg level in range of 80-110 mg/dl.

Eligibility criteria:
inclusion criteria: * all postoperative patients who will be admitted to surgical icu and developed post surgical hyperglycemia will be eligible for evaluation for inclusion and exclusion criteria exclusion criteria: * all patients having diabetes mellitus, history of preoperative stress hyperglycemia, endocrinopathies, obesity defined as body mass index (bmi) \>30 kg/m2, age younger than 18 years, renal impairment or maintenance on renal replacement therapy and liver diseases.